Because bioequivalence studies are performed using a crossover design, information on the intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs based on bioequivalence results of identical generic drugs produce different estimates. In this study, we collected bioequivalence results using public resources from the Ministry of Food and Drug Safety (MFDS) and calculated the intra-CVs of various generics. For the generics with multiple bioequivalence results, pooled intra-CVs were calculated. The estimated intra-CVs of 142 bioequivalence studies were 14.7±8.2% for AUC and 21.7±8.8% for C(max). Intra-CVs of C(max) were larger than those of area under the concentration-time curve (AUC) in 129 studies (90.8%). For the 26 generics with multiple bioequivalence results, the coefficients of variation of intra-CVs between identical generics (mean±sd (min ~ max)) were 38.0±24.4% (1.9 ~ 105.3%) for AUC and 27.9±18.2 % (4.0 ~ 70.1%) for C(max). These results suggest that substantial variation exists among the bioequivalence results of identical generics. In this study, we presented the intra-CVs of various generics with their pooled intra-CVs. The estimated intra-CVs calculated in this study will provide useful information for planning future bioequivalence studies.
Area Under Curve ; Cross-Over Studies ; Drugs, Generic ; Sample Size* ; Therapeutic Equivalency*

The retraction has been agreed upon due to critical typographical errors throughout the contents from accidents at the manuscript editing step.

Because bioequivalence studies are performed using a crossover design, information on the intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs based on bioequivalence results of identical generic drugs produce different estimates. In this study, we collected bioequivalence results using public resources from the Ministry of Food and Drug Safety (MFDS) and calculated the intra-CVs of various generics. For the generics with multiple bioequivalence results, pooled intra-CVs were calculated. The estimated intra-CVs of 142 bioequivalence studies were 14.7±8.2% for AUC and 21.7±8.8% for Cmax. Intra-CVs of Cmax were larger than those of area under the concentration-time curve (AUC) in 129 studies (90.8%). For the 26 generics with multiple bioequivalence results, the coefficients of variation of intra-CVs between identical generics (mean±sd (min ~ max)) were 38.0±24.4% (1.9 ~ 105.3%) for AUC and 27.9±18.2% (4.0 ~ 70.1%) for Cmax. These results suggest that substantial variation exists among the bioequivalence results of identical generics. In this study, we presented the intra-CVs of various generics with their pooled intra-CVs. The estimated intra-CVs calculated in this study will provide useful information for planning future bioequivalence studies. (This is republication of the article 'Transl Clin Pharmacol 2017;25:179-182' retracted from critical typographic errors. See the 'Retraction and Republication section of this issue for further information)
Area Under Curve ; Cross-Over Studies ; Drugs, Generic ; Sample Size ; Therapeutic Equivalency

Purpose: This study investigated the dose perturbation according to the size of the sensitive volume in the dosimeter in small-field dosimetry. Methods: The dose profiles with different field sizes were measured using three different dosimeters: the CC13, Razor ion chamber, and Edge solid-state detector. Both the open and wedged beams with different field sizes were employed in the measurement. The profiles were measured in a water phantom at maximum dose depths of 5, 10, and 20 cm. The penumbra and width of the open-beam profiles were compared according to the types of the dosimeters and beam. The dose fall-off between the peak and 20% dose was evaluated for the wedged beam profiles. Results: In the open-beam measurement, the fall-off of the profile was steeper with the Edge detector, which has the smallest sensitive volume. Meanwhile, the dose in the out-of-field region was the smallest with the Edge detector. The widths of the penumbra were 6.10, 4.47, and 4.03 mm for the profile of the 3×3 cm 2 field measured by the CC13 chamber, Razor chamber, and Edge detector, respectively. The width of the profile was not changed even if different dosimeters were used in the measurement. The wedged beam profiles showed more clear peaks at the field edge when a smaller dosimeter was used. Conclusions The results demonstrate the necessity of dosimeters with a small sensitive volume for measuring a small-field beam or a steep dose gradient.

Purpose: This study investigated the dose perturbation according to the size of the sensitive volume in the dosimeter in small-field dosimetry. Methods: The dose profiles with different field sizes were measured using three different dosimeters: the CC13, Razor ion chamber, and Edge solid-state detector. Both the open and wedged beams with different field sizes were employed in the measurement. The profiles were measured in a water phantom at maximum dose depths of 5, 10, and 20 cm. The penumbra and width of the open-beam profiles were compared according to the types of the dosimeters and beam. The dose fall-off between the peak and 20% dose was evaluated for the wedged beam profiles. Results: In the open-beam measurement, the fall-off of the profile was steeper with the Edge detector, which has the smallest sensitive volume. Meanwhile, the dose in the out-of-field region was the smallest with the Edge detector. The widths of the penumbra were 6.10, 4.47, and 4.03 mm for the profile of the 3×3 cm 2 field measured by the CC13 chamber, Razor chamber, and Edge detector, respectively. The width of the profile was not changed even if different dosimeters were used in the measurement. The wedged beam profiles showed more clear peaks at the field edge when a smaller dosimeter was used. Conclusions The results demonstrate the necessity of dosimeters with a small sensitive volume for measuring a small-field beam or a steep dose gradient.

Purpose: This study investigated the dose perturbation according to the size of the sensitive volume in the dosimeter in small-field dosimetry. Methods: The dose profiles with different field sizes were measured using three different dosimeters: the CC13, Razor ion chamber, and Edge solid-state detector. Both the open and wedged beams with different field sizes were employed in the measurement. The profiles were measured in a water phantom at maximum dose depths of 5, 10, and 20 cm. The penumbra and width of the open-beam profiles were compared according to the types of the dosimeters and beam. The dose fall-off between the peak and 20% dose was evaluated for the wedged beam profiles. Results: In the open-beam measurement, the fall-off of the profile was steeper with the Edge detector, which has the smallest sensitive volume. Meanwhile, the dose in the out-of-field region was the smallest with the Edge detector. The widths of the penumbra were 6.10, 4.47, and 4.03 mm for the profile of the 3×3 cm 2 field measured by the CC13 chamber, Razor chamber, and Edge detector, respectively. The width of the profile was not changed even if different dosimeters were used in the measurement. The wedged beam profiles showed more clear peaks at the field edge when a smaller dosimeter was used. Conclusions The results demonstrate the necessity of dosimeters with a small sensitive volume for measuring a small-field beam or a steep dose gradient.

Purpose: This study investigated the dose perturbation according to the size of the sensitive volume in the dosimeter in small-field dosimetry. Methods: The dose profiles with different field sizes were measured using three different dosimeters: the CC13, Razor ion chamber, and Edge solid-state detector. Both the open and wedged beams with different field sizes were employed in the measurement. The profiles were measured in a water phantom at maximum dose depths of 5, 10, and 20 cm. The penumbra and width of the open-beam profiles were compared according to the types of the dosimeters and beam. The dose fall-off between the peak and 20% dose was evaluated for the wedged beam profiles. Results: In the open-beam measurement, the fall-off of the profile was steeper with the Edge detector, which has the smallest sensitive volume. Meanwhile, the dose in the out-of-field region was the smallest with the Edge detector. The widths of the penumbra were 6.10, 4.47, and 4.03 mm for the profile of the 3×3 cm 2 field measured by the CC13 chamber, Razor chamber, and Edge detector, respectively. The width of the profile was not changed even if different dosimeters were used in the measurement. The wedged beam profiles showed more clear peaks at the field edge when a smaller dosimeter was used. Conclusions The results demonstrate the necessity of dosimeters with a small sensitive volume for measuring a small-field beam or a steep dose gradient.

Purpose: This study investigated the dose perturbation according to the size of the sensitive volume in the dosimeter in small-field dosimetry. Methods: The dose profiles with different field sizes were measured using three different dosimeters: the CC13, Razor ion chamber, and Edge solid-state detector. Both the open and wedged beams with different field sizes were employed in the measurement. The profiles were measured in a water phantom at maximum dose depths of 5, 10, and 20 cm. The penumbra and width of the open-beam profiles were compared according to the types of the dosimeters and beam. The dose fall-off between the peak and 20% dose was evaluated for the wedged beam profiles. Results: In the open-beam measurement, the fall-off of the profile was steeper with the Edge detector, which has the smallest sensitive volume. Meanwhile, the dose in the out-of-field region was the smallest with the Edge detector. The widths of the penumbra were 6.10, 4.47, and 4.03 mm for the profile of the 3×3 cm 2 field measured by the CC13 chamber, Razor chamber, and Edge detector, respectively. The width of the profile was not changed even if different dosimeters were used in the measurement. The wedged beam profiles showed more clear peaks at the field edge when a smaller dosimeter was used. Conclusions The results demonstrate the necessity of dosimeters with a small sensitive volume for measuring a small-field beam or a steep dose gradient.

Purpose: This study evaluated various methods for determining the half-value layer (HVL) of kilovoltage (kV) beams produced by the Varian TrueBeam STx on-board imager. By comparing these methods with the standard ionization chamber approach, the study aimed to identify practical solutions for HVL determination and dosimetric characterization of kV beams, particularly in resource-limited settings. Methods: HVLs for kV beams (40–140 kVp) were measured using an Exradin A12 ionization chamber and a Piranha MULTI meter. The ionization chamber measurements adhered to American Association of Physicists in Medicine Task Group 61 guidelines and served as the reference standard. Additionally, HVL values were calculated using two model-based approaches: SpekPy (a Python-based tool) and Monte Carlo (MC) simulations using Geant4 and GATE. The results from these methods were compared to assess consistency and reliability. Results: Deviations across all methods were generally below 4%. At 40 kV, the most significant discrepancies were attributed to lower signal levels from the ionization chamber. The consistency between the model-based methods and experimental measurements demonstrates the reliability of these alternative approaches for HVL determination. Conclusions Although the ionization chamber remains the gold standard, the Piranha MULTI meter and model-based methods, i.e., SpekPy and MC simulations, have shown promise as viable alternatives, especially in resource-constrained settings. These in silico approaches also offer advantages in convenience and accuracy, supporting their potential for broader future applications.

Purpose: Brachytherapy is essential for treating gynecological cancers as it offers precise radiation delivery to tumors while minimizing radiation exposure to surrounding healthy tissues. The Geneva applicator, introduced in 2020 as a replacement for older models like the Utrecht applicator, enhances MRI-based brachytherapy with improved imaging capabilities and more accurate applicator placement. In 2021, updates to non-reimbursement policies in Korea for MRI-based 3D brachytherapy planning further promoted the adoption of advanced techniques such as the Geneva applicator. This study aims to commission the Geneva applicator, focusing on wall thickness, dummy marker positions, and source dwell positions to ensure accurate dose delivery and safety. Methods: The commissioning process involved measuring wall thickness in both the longitudinal and transverse directions for the tandem and lunar-shaped ovoid tubes and comparing thesemeasurements with the manufacturer’s specifications. Dummy marker positions were verifiedusing CT imaging, with a focus on alignment tolerances of ±1 mm. Source dwell positions were planned using the Oncentra treatment planning system, with measurements taken using EBT4 film and analyzed with RIT software. Results: Wall thickness measurements and dummy marker positions were within the specified tolerance ranges, confirming their accuracy. The source dwell positions, measured and analyzedthrough multiple tests, were all within the ±1 mm tolerance, ensuring the applicator’s reliability. Conclusions The Geneva applicator met all standards for safe and effective use in brachytherapy.The use of a 3D-printed holder was crucial for precise alignment and measurement. With updated reimbursement policies in Korea for MRI-based brachytherapy, the Geneva applicator is expected to significantly impact the future of advanced brachytherapy treatments and research.